BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 1905110 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04941
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE DEVICE REVEALED THAT THE GUIDE CATHETER WAS RECEIVED INSIDE THE PUSH CATHETER ASSEMBLY. THE GUIDE CATHETER WAS DETACHED FROM THE PULLWIRE. THE PULLWIRE WAS KINKED/BENT AT MULTIPLE LOCATIONS NEAR THE PROXIMAL END OF THE DEVICE. THE STENT WAS NOT RETURNED FOR EVALUATION. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PRELOADED ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BROKE DURING THE STENT DEPLOYMENT ATTEMPT. THERE PHYSICIAN WAS ABLE TO WITHDRAW THE ENTIRE DEVICE AS THE GUIDE CATHETER DID NOT DETACH FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PRELOADED ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PRELOADED ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BROKE DURING THE STENT DEPLOYMENT ATTEMPT. THERE PHYSICIAN WAS ABLE TO WITHDRAW THE ENTIRE DEVICE AS THE GUIDE CATHETER DID NOT DETACH FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PRELOADED ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00534340 13546383

    Patients

    Seq Age Sex Outcome Treatment
    1